Associate Regulatory Affairs Specialist

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments. Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections.In this role, you will support the preparation and submission of regulatory documentation for medical device registrations in Vietnam, ensuring compliance with local regulations. A typical day involves collaborating with cross-functional teams and global Regulatory Affairs partners to manage product registrations, maintain regulatory records, and monitor regulatory updates. You will also support regulatory inspections and audits, review labeling and promotional materials for compliance, and maintain effective communication with local health authorities to ensure timely approvals and continued market access.

Responsibilities may include the following and other duties may be assigned:

• Prepare, review, submit, and maintain regulatory documentation for medical device registrations in Vietnam in compliance with local regulatory requirements.

• Support pre-market and post-market regulatory activities to ensure timely product approvals and continued market access.

• Collaborate closely with Operating Units, regional/global Regulatory Affairs teams, and cross-functional stakeholders to support product registration strategies and marketing authorizations.

• Monitor changes in Vietnam regulatory requirements and assess potential business impacts; provide timely regulatory updates.

• Maintain effective communication with local health authorities and ensure proper documentation and tracking of all regulatory correspondences and submissions.

• Support regulatory inspections, internal audits, and notified body audits as required.

• Assist in developing, reviewing, and updating regulatory procedures, work instructions, and related documentation to ensure compliance with applicable regulations and company policies.

• Maintain accurate regulatory files, databases, records, and tracking systems to ensure systematic retrieval and reporting of regulatory information.

• Review & manage product labeling if any, promotional materials, and advertising content to ensure compliance with local regulatory and company requirements.

Required Knowledge and Experience: 

• Bachelor’s degree in Medical, Biomedical Engineering, Pharmacy, Life Sciences, or other healthcare-related disciplines.

• 2-3 year’s experience for RA role in medical device and or pharmaceutical industry. 

• Good understanding for regulations and policies issued by Vietnam ability to interpret international regulatory requirements.

• Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude.

• Strong attention to details and ability to handle multiple tasks, good at planning and can work under pressure, Good at English including reading, writing, and speaking.

• Good Learning attitude.

• Experience working with cross-functional teams.

• Effective verbal and written communication skills both internally and externally.

• Experience with solving problems and concerns.

• Experience with project management and adherence to time schedules.

• Work well under pressure in a dynamic environment.

• Highly organized, detail-oriented, and efficient.

• Team player who seeks to help and learn from colleagues seeing the department success as their own. 

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here